SCANLAN VASCULAR TUNNELER AND BULLET TIP

Additional Manufacturer Narrative

THE TUNNELER SHEATH AND BULLET TIP WERE NOT RETURNED FOR FURTHER ANALYSIS AND NO FURTHER INFORMATION WAS MADE AVAILABLE FROM THE REPORTING INSTITUTION. REVIEW OF THE DESIGN, MANUFACTURING BATCH RECORD, AND TECHNICAL DOCUMENTATION FOUND NO NON-CONFORMITIES. INSPECTION OF PRODUCT FROM THE CURRENT PRODUCTION LOT INDICATE THAT THE TUNNELER SHEATHS AND BULLET TIPS MEET SPECIFICATIONS AND PERFORM AS INTENDED. THE SURGEON ATTEMPTED TO PASS THE TUNNELER IN THE LEG AND PULL BACK, THE BULLET DISLODGED FROM THE TUNNELER. THE TUNNELER SHEATH AND BULLET TIP ASSEMBLY WAS REVERSED WHEN THE BULLET TIP WAS DISLODGED WHICH IS A KNOWN ISSUE AS IT IS CAUTIONED IN THE PRODUCT IFU. ADDITIONALLY, THE TUNNELER SHEATH AND BULLET TIP ARE SINGLE USE AND NOT INTENDED TO BE REUSED. ONCE THE SHEATH AND BULLET TIP ARE ASSEMBLED, THEY ARE NOT INTENDED TO BE SEPARATED AND ASSEMBLED AGAIN. NO EVIDENCE OF PRODUCT NON-CONFORMITY.

Description of Event or Problem

"THE SURGEON ATTEMPTED TO PASS THE TUNNELER IN THE LEG AND PULL BACK, THE BULLET TIP DISLODGED FROM THE TUNNELER AND NEEDED TO BE RETREIVED FROM THE LOWER CALF. THIS CREATED A NEED FOR SEPERATION IN THE MUSCLE LAYER TO CUT DOWN AND RETRIEVE. THIS ITEM WAS REMOVED FROM THE FIELD, INSPECTED , AND FOUND THAT THE TWO PIECE DISPOSABLE SYSTEM DID NOT FIT CORRECTLY ON THE INSTRUMENT. A NEW 9009-18 SCANLAN TUNNELER AND BULLET TIP WERE OPENED, INSPECTED AND FOUND TO BE WITHOUT DEFECT." AS REPORTED.